Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
This study is currently recruiting participants.
Verified December 2012 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00892450
First received: April 28, 2009
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease Overactive Bladder |
Drug: Oxybutynin and darifenacin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- compare cognitive side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 22 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
crossover design
|
Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.
|
Detailed Description:
This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD (ICD9=332.0)
- MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
Urological work-up within 3 months of enrollment to:
Rule out treatable causes of urinary symptoms
- Urinalysis (UA)
- Post-void residual ultrasound (PVR)
- Urinary cytology
Documented symptoms OAB on screening 3-day voiding diary:
- Average of 1 urgency episode / 24 hours, and
- Average of 8 micturitions / 24 hours
- Subjective complaints of symptoms for 3 months
Exclusion Criteria:
- Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
- Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
- Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
- Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
- Uncontrolled narrow angle glaucoma
- History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
- History of hepatic or renal impairment
- History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
- Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892450
Contacts
| Contact: Heidi C Watson | (215) 823-5800 ext 3297 | heidi.watson@va.gov |
Locations
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jayne R Wilkinson, MD 215-823-5800 ext 5934 jayne.wilkinson@va.gov | |
| Contact: John E Duda, MD (215) 823-5934 john.duda@va.gov | |
| Sub-Investigator: Dan Weintraub, MD | |
| Principal Investigator: Jayne R. Wilkinson, MD | |
| Sub-Investigator: Keith Van Arsdalen, MD | |
| Sub-Investigator: Paul Moberg, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Jayne R. Wilkinson, MD | VA Medical Center, Philadelphia |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00892450 History of Changes |
| Other Study ID Numbers: | 01143 |
| Study First Received: | April 28, 2009 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Overactive bladder symptoms Parkinson's disease darifenacin oxybutynin cognition |
Additional relevant MeSH terms:
|
Parkinson Disease Urinary Bladder, Overactive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms |
Oxybutynin Darifenacin Cholinergic Antagonists Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013